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Fusion peptide therapeutic compositions

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Title: Fusion peptide therapeutic compositions.
Abstract: Therapeutic compositions containing fusion proteins (FPs) including elastin-like peptides (ELPs) and peptide active therapeutic agents, and methods of making and using such compositions and fusion proteins. Therapeutic compositions of such type enable improved efficacy of the peptide active therapeutic agent to be achieved, in relation to the peptide active therapeutic agent alone. Enhanced efficacy of the peptide active therapeutic agent in the therapeutic composition may include improved solubility, bioavailability, bio-unavailability, half-life, etc., as compared to corresponding compositions containing the same peptide active therapeutic agent without associated ELPs. ...


Browse recent Cooley LLP Attn: Patent Group patents - Washington, DC, US
Inventor: Ashutosh Chilkoti
USPTO Applicaton #: #20110039776 - Class: 514 117 (USPTO) - 02/17/11 - Class 514 


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The Patent Description & Claims data below is from USPTO Patent Application 20110039776, Fusion peptide therapeutic compositions.

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RELATED APPLICATION DATA

The application claims priority under 35 U.S.C. §119(e) to U.S. Patent application Ser. No. 60/842,464, filed Sep. 6, 2006, incorporated by reference herein in its entirety.

FIELD OF THE INVENTION

The invention provides a new generation of therapeutic compositions, incorporating fusion proteins (FPs) including elastin-like peptides (ELPs) and peptide active therapeutic agents. The therapeutic compositions of the invention enable improved solubility, bioavailability or bio-unavailability, and half-life of the administered peptide active therapeutic agents to be achieved, as compared to corresponding compositions containing the same peptide active therapeutic agents without associated ELPs.

BACKGROUND OF THE INVENTION

The disclosures of U.S. Pat. No. 6,852,834, issued Feb. 8, 2005 in the name of Ashutosh Chilkoti for “FUSION PEPTIDES ISOLATABLE BY PHASE TRANSITION,” and U.S. patent application Ser. No. 11/053,100 filed Feb. 8, 2005 in the name of Ashutosh Chilkoti for “FUSION PEPTIDES ISOLATABLE BY PHASE TRANSITION,” are hereby incorporated herein by reference, in their respective entireties, for all purposes.

The aforementioned Chilkoti patent and patent application disclose genetically-encodable, environmentally-responsive fusion proteins comprising ELP peptides. Such fusion proteins exhibit unique physico-chemical and functional properties that can be modulated as a function of solution environment.

SUMMARY

OF THE INVENTION

The present invention relates broadly to fusion protein (FP) therapeutic compositions including elastin-like peptides (ELPs) and peptide active therapeutic agents.

In the FP therapeutic compositions of the invention, at least one peptide active therapeutic agent is coupled to one or more ELPs, e.g., being covalently bonded at an N- or C-terminus thereof, to achieve enhancement of the efficacy of the peptide active therapeutic agent(s), in relation to the corresponding therapeutic agent(s) alone. The peptide active therapeutic agent-ELP construct has enhanced efficacy in respect of any of various properties, such as solubility, bioavailability, bio-unavailability, therapeutic dose, resistance to proteolysis, half-life of the administered peptide active therapeutic agent, etc.

In another aspect, the invention relates to fusion gene constructs, including heterologous nucleotide sequences operably linked to an expression control element, e.g., a promoter of appropriate type, wherein the heterologous nucleotide sequences encode a fusion protein including at least one peptide active therapeutic agent coupled to at least one ELP.

In a further aspect, the invention relates to a method of enhancing efficacy of a peptide active therapeutic agent. The method includes coupling the peptide active therapeutic agent with at least one ELP to form a FP therapeutic composition, wherein the peptide active therapeutic agent in such FP therapeutic composition has enhanced efficacy, in relation to the peptide active therapeutic agent alone. In one aspect the enhanced efficacy is in vivo efficacy.

Another aspect of the invention relates to a method of treating a subject in need of a peptide active therapeutic agent, including administering to the patient a therapeutic composition including: (i) the peptide active therapeutic agent to coupled with at least one ELP, or (ii) a nucleotide sequence encoding a fusion protein including the peptide active therapeutic agent and at least one ELP, operably linked to an expression control element therefore.

In still another aspect, the invention relates to a therapeutic agent dose form, in which the therapeutic agent is conjugated with an ELP.

Various other aspects, features and embodiments of the invention will be more fully apparent from the ensuing disclosure and appended claims.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1 is an SDS-PAGE gel showing expression of a 37 amino acid peptide, using the expression and purification methods of Example 1.

FIG. 2 is a graph confirming the purification of the peptides resulting from the methods of Example 1.

FIG. 3 is an SDS-PAGE gel showing the results of ITC purification of BFP, CAT and K1-3, as set forth in Example 6.

FIGS. 4A and 4B are graphs of the increase in turbidity as a function of temperature of each of the fusion constructs of Example 8 in PBS buffer.

FIG. 5 is graph illustrating the blood concentration time-course for 14C labeled ELP, as set forth in Example 9.

FIG. 6 is a graph showing biodistribution of 14C labeled ELP1-150 and ELP 2-160 in nude mice, as described in Example 10.

FIG. 7 is a graph showing biodistribution of 14C labeled ELP2-[V1A8G7-160] in nude mice, as described in Example 10.



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stats Patent Info
Application #
US 20110039776 A1
Publish Date
02/17/2011
Document #
12440294
File Date
09/06/2007
USPTO Class
514 117
Other USPTO Classes
International Class
61K38/26
Drawings
4



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